RECRUITING

Kesimpta (Ofatumumab) Pregnancy Registry

Conditions

Multiple Sclerosis Pregnancy PASS Kesimpta ofatumumab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The Kesimpta Pregnancy Registry is an observational, exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS.

Official Title

Post-Authorization Safety Study for Assessment of Pregnancy and Infant Outcomes in Patients Treated With Kesimpta (Ofatumumab) Using OTIS Observational Pregnancy Surveillance Program and DMSKW Registry

Quick Facts

Study Start:2023-01-05

Study Completion:2033-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05634967

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Pregnant women 2. Diagnosed with MS, with the indication validated by medical records when possible 3. Administered Kesimpta for the treatment of MS at any time from 166 days prior to the first day of the LMP, or up to and including the end of pregnancy 4. Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born children 1. Pregnant women 2. Diagnosed with MS, with the indication validated by medical records when possible 3. May or may not have taken another medication for MS in the current pregnancy 4. Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born children 1. Pregnant women 2. Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants, and validated developmental performance questionnaire in live born children	1. Women who have enrolled in the Kesimpta cohort study with a previous pregnancy 2. Women who have used Kesimpta for an indication other than a currently approved indication 3. Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) prior to conception: * Other anti-CD20 monoclonal antibody: same class as Kesimpta * S1P modulators: same class as Mayzent * Cladribine (Mavenclad): Based on the US label, animal studies indicate that there is positive evidence of teratogenicity for Cladribine * Teriflunomide (Aubagio): The teratogenecity of teriflunomide is unknown and currently under investigation. * New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses. 4. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment) 5. Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect. 1. Administered Kesimpta 166 days before the first day of LMP or anytime during pregnancy 2. Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) of conception: * Anti CD-20 monoclonal antibody * Cladribine (Mavenclad) * S1P modulators * Teriflunomide (Aubagio) New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses. 3. Women who have enrolled in the Kesimpta cohort or BAF312A2403 Mayzent cohort with a previous pregnancy 4. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment) 5. Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect. 1. Administered Kesimpta 166 days before or Mayzent 4 days after the first day of LMP or anytime during pregnancy 2. Women who have a diagnosis of a MS 3. Women who have a current diagnosis of any autoimmune disease 4. Women who have first contact with the project after prenatal diagnosis of any major structural defect 5. Women treated with Mayzent or Kesimpta for non-MS indication 6. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment) 7. Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect. 8. Women exposed to a known human teratogenic drugs during pregnancy

Inclusion Criteria

Exclusion Criteria

1. Pregnant women
2. Diagnosed with MS, with the indication validated by medical records when possible
3. Administered Kesimpta for the treatment of MS at any time from 166 days prior to the first day of the LMP, or up to and including the end of pregnancy
4. Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born children
1. Pregnant women
2. Diagnosed with MS, with the indication validated by medical records when possible
3. May or may not have taken another medication for MS in the current pregnancy
4. Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born children
1. Pregnant women
2. Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants, and validated developmental performance questionnaire in live born children

1. Women who have enrolled in the Kesimpta cohort study with a previous pregnancy
2. Women who have used Kesimpta for an indication other than a currently approved indication
3. Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) prior to conception:
* Other anti-CD20 monoclonal antibody: same class as Kesimpta
* S1P modulators: same class as Mayzent
* Cladribine (Mavenclad): Based on the US label, animal studies indicate that there is positive evidence of teratogenicity for Cladribine
* Teriflunomide (Aubagio): The teratogenecity of teriflunomide is unknown and currently under investigation.
* New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses.
4. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
5. Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
1. Administered Kesimpta 166 days before the first day of LMP or anytime during pregnancy
2. Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) of conception:
* Anti CD-20 monoclonal antibody
* Cladribine (Mavenclad)
* S1P modulators
* Teriflunomide (Aubagio) New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses.
3. Women who have enrolled in the Kesimpta cohort or BAF312A2403 Mayzent cohort with a previous pregnancy
4. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
5. Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
1. Administered Kesimpta 166 days before or Mayzent 4 days after the first day of LMP or anytime during pregnancy
2. Women who have a diagnosis of a MS
3. Women who have a current diagnosis of any autoimmune disease
4. Women who have first contact with the project after prenatal diagnosis of any major structural defect
5. Women treated with Mayzent or Kesimpta for non-MS indication
6. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
7. Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
8. Women exposed to a known human teratogenic drugs during pregnancy

Contacts and Locations

Study Contact

Novartis Pharmaceuticals

CONTACT

1-888-669-6682

novartis.email@novartis.com

Diana Johnson

CONTACT

1-877-311-8972

mothertobaby@health.ucsd.edu

Principal Investigator

Novartis Pharmaceuticals

STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Locations (Sites)

Novartis Investigative Site

La Jolla, California, 92093

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-05

Study Completion Date2033-02-28

Study Record Updates

Study Start Date2023-01-05

Study Completion Date2033-02-28

Terms related to this study

Keywords Provided by Researchers

PASS
Kesimpta
ofatumumab
Pregnancy
Multiple Sclerosis

Additional Relevant MeSH Terms

Multiple Sclerosis
Pregnancy